J&J's COVID vaccine taken by 19 million Americans is PULLED by FDA after it was paused 'out of an abundance of caution' over rare blood clot concerns - which led to a plummet in demand
The Food and Drug Administration (FDA) has revoked authorization of Johnson & Johnson’s Covid vaccine after it was paused over rare blood clot concerns, which sent demand plummeting.
The Food and Drug Administration (FDA) has revoked authorization of Johnson & Johnson’s Covid vaccine after it was paused over rare blood clot concerns, which sent demand plummeting.
The move was not unexpected because J&J’s parent company Jannsen had requested that federal regulators at the FDA withdraw authorization for its vaccine after it was revealed that the last tranche of doses – about 12.5 million – had expired.
As of year three of the Covid pandemic, nearly 231 million Americans have received either one J&J shot or two doses of an mRNA vaccine from Pfizer or Moderna.
Citing ever-shrinking demand, J&J told the FDA it would not update formulations of its shot to confront emerging strains better, a step that Moderna and Pfizer took last year to address the devastating omicron variant.
Dr Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research said: ‘Because FDA understands that… Janssen Biotech, Inc. has requested that FDA withdraw the EUA for the Janssen COVID-19 Vaccine, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization.’
A fraction of Americans have received J&J’s vaccine compared to the other vaccines approved for use in the US.
Nearly 367 million Americans have received a Pfizer shot while over 232 million have received a dose of Moderna’s vaccine. A paucity of the total shots administered in the US since early 2021 – just over 19 million – were made by J&J.
Johnson & Johnson’s vaccine was plagued by controversy since it entered the market in February 2021. By that time, more than 2.1 million mRNA shots had already been administered and those from Pfizer and Moderna became the gold standard.
Less than a month after the J&J vaccine was granted emergency use authorization from the FDA, it became mired in controversy over a small but growing number of severe blood clotting disorders called thrombosis with thrombocytopenia syndrome (TTS) in people who got the shot.
Thrombosis with thrombocytopenia syndrome is a severe condition characterized by thrombosis formation, or blood clots, combined with thrombocytopenia, a severely low platelet count that hinders the body's ability to stop a wound from bleeding.
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They sure love the number 19.